PHILADELPHIA, Sept. 21, 2015 (GLOBE NEWSWIRE
) — Hemispherx Biopharma (NYSE MKT:HEB) announces the publication of an online peer reviewed research article of an analysis of clinical data on its investigational therapeutic, Ampligen, entitled, “Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME); Characteristics of Responders to Rintatolimod” in the current issue of Journal of Drug Research and Development. The team of authors is composed of Hemispherx staff, consultants and leading independent clinical experts in CFS/ME in the United States.
Data from a previous Phase III clinical trial of Ampligen in patients with CFS/ME were retrospectively analyzed to determine whether baseline exercise tolerance (ET) could be used to predict responses to Ampligen (rintatolimod) vs. placebo. A modified Bruce ET treadmill test was used because of the severe physical exercise intolerance of CFS patients.
Analysis of significant improvement in exercise performance at the ? 25% and ? 50% levels using ET at 40 weeks compared to baseline was performed for the intent-to-treat (ITT) population (n=208) using a baseline exercise threshold ET of greater than 9 minutes. For this subset of patients with baseline ET >9 minutes, 33% of patients on Ampligen®, an experimental therapeutic, vs. 12% of patients on placebo improved ET duration by ? 25% (p=0.004) while 23% of Ampligen® treated patients improved by ? 50% compared to 4.5% placebo patients (p=0.003).
A continuous responder analysis provided further support for a significant clinical enhancement in the ET effect in the Ampligen® cohorts as compared to placebo.
The Karnofsky Performance Score (KPS) and Vitality (SF-36 subscale) quality of life secondary endpoint also demonstrated similar clinically significant improvements for the cohort of study subjects with baseline ET > 9 minutes, as a function of the same ET parameters. Importantly, these improvements, the 10 point increase in KPS and 14.6 point increase in vitality scores, are both considered by the authors to reflect clinically significant changes that represent objective improvement in the quality of life. Ampligen®, an experimental therapeutic, also reduced deterioration in ET compared to placebo in patients who failed to improve physically.
Taken in context with the recent peer reviewed publication pointing to reduced NK function in CFS/ME patients, (entitled “Low NK Cell Activity in Chronic Fatigue Syndrome (CFS) and Relationship to Symptom Severity” in which 17 studies were reviewed that evaluated NK cell cytotoxicity (NKCC) data and the relationship to different CFS case definitions and CFS disease severity, Journal of Clinical and Cellular Immunology (Strayer D, et al, J Clin Cell Immunol 2015;6:4 http://doi.org/10.4172/2155-9899.1000348), a new set of evidence based criteria have now been identified which may assist in selection of CFS/ME patients who may derive significant benefit clinically from therapeutic intervention with selective TLR-3-dsRNA activators. “In context, this clear statistical improvement corroborates our independent clinical experts, who indicate that they have also identified criteria predictive of responsiveness to our experimental drug Ampligen®”, states Tom Equels, President of Hemispherx.
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About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharmaceutical company headquartered in Philadelphia, Pennsylvania and engaged in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases including cancers. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company’s Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name “Naturaferon”) for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
The information in this press release includes certain “forward-looking” statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The production of new Alferon® API inventory will not commence until the capital improvement and validation phases are complete. While the facility is approved by FDA under the Biological License Application (“BLA”) for Alferon®, this status will need to be reaffirmed upon the completion of the facility’s enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. The final results of these and other ongoing activities could vary materially from Hemispherx’s expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries. The re-launch of Alferon® N as a commercial product cannot commence until all regulatory approvals have been obtained.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; as well as numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx’s expectations. Finally, the projection of savings above is subject to change based upon operational requirements of the company and the possibility that additional finance and accounting staff may be required to accomplish the Company’s goals and objectives.
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “intends,” “plans,” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx’s filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.